Olanzapine
- Product NDC
- 55111-163
- 11-digit product format
- 551110163
- Labeler code
- 55111
- Product ID
- 55111-163_ba26436d-7009-476f-23b0-45676a0e7805
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Olanzapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Dr. Reddy's Laboratories Ltd.
- Application
- ANDA076255
- Marketing category
- ANDA
- Marketing start
- 2012-04-23
- Substance
- OLANZAPINE
- Active strength
- 2.5 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Olanzapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OLANZAPINE | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N7U69T4SZR |
| Rxcui | 200034 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55111-163-01 | Olanzapine | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 15 |
| 55111-163-05 | Olanzapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 55111-163-30 | Olanzapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
| 55111-163-78 | Olanzapine | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 15 |
| 55111-163-79 | Olanzapine | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| olanzapine | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED] | 8 | |
| olanzapine | ACTIVE INGREDIENT | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| OLANZAPINE | ACTIVE MOIETY | N7U69T4SZR | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| Crospovidone | INACTIVE INGREDIENT | 68401960MK | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | OLANZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55111-163 | OLANZAPINE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LTD.] | 15 | Current NDC, Legacy NDC, 5 package rows | 20221005_9a57a63e-f856-aafa-037a-c08f2fea6496.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55111-163-01 | 55111016301 | 100 TABLET, FILM COATED in 1 BOTTLE (55111-163-01) | | 2012-04-23 | 0000-00-00 | No | No | Current |
| 55111-163-05 | 55111016305 | 500 TABLET, FILM COATED in 1 BOTTLE (55111-163-05) | | 2012-04-23 | 0000-00-00 | No | No | Current |
| 55111-163-30 | 55111016330 | 30 TABLET, FILM COATED in 1 BOTTLE (55111-163-30) | | 2012-04-23 | 0000-00-00 | No | No | Current |
| 55111-163-78 | 55111016378 | 10 BLISTER PACK in 1 CARTON (55111-163-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-163-79) | 10 blister pack | 2012-04-23 | 0000-00-00 | No | No | Current |
| 55111-163-79 | 55111016379 | 10 in 1 BLISTER PACK | | | | | | Historical |